FDA Registration Active 🇧🇷 Brazil

ALACER INDUSTRIA ELETRONICA LTDA

Reg #: 3016854619 · FEI: 3016854619 · Expires 2026
Products
4
Proprietary Names
180
Establishment Types
1
Classifications
4

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Registration Details

Registration Name
ALACER INDUSTRIA ELETRONICA LTDA
Registration Number
3016854619
FEI Number
3016854619
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rua Batista de Melo 113, Jardim Jabaquara
City
Sao Paulo
Country
BR

Regulatory Submissions

510(k) Number
K160170

Owner / Operator

Firm Name
ALACER INDUSTRIA ELETRONICA LTDA
Operator Number
10086657
Address
Rua Batista de Melo 113, Jardim Jabaquara
City
Sao Paulo
State
BR-SP
Postal Code
04383-080
Country
BR
Correspondent
Iracele Alkimim Sanches

US Agent

Business Name
Grupo Red International Corporation
Contact Name
Juan Caballero
Address
1101 Brickell Ave
City
Miami
State
FL
ZIP
33131
Country
US
Phone
786 7173600

Products

Device Name Product Code
Electrode, Ph, Stomach FFT
Device, Cystometric, Hydraulic FEN
System, Gastrointestinal Motility (Electrical) FFX
System, Breath Measurement NRH

Proprietary Names

AL-4 Catheter pHmetry Esophageal (2CpHAL4AD8cm) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-20cm) pH Monitoring Probe (PH2C5CM) pH Monitoring Probe (PH2C19CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD15cm) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101521UU) pH Monitoring Probe (PH2C16CM) AL-4 Catheter pHmetry Esophageal - External Reference (11PHAL4PD1,9UU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD7CMUU) AL-4 Catheter pHmetry Esophageal (1CpHAL4AD) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51520UU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z20CMRE) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD20cm) pH Monitoring Probe (PH3C-13-24CM) pH Monitoring Probe (PH2C7CM) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z7CMPDUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z20CMUU) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z16CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4AD1,4UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD12cm) pH Monitoring Probe (PH2C17CM) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD7-23cm) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z14CMRE) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101821) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1520UU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z22CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1519UU) pH Monitoring Probe (PH3C-7-23CM) pH Monitoring Probe (PH1C-PED1,9) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4PD1,4UU) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z12CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD18CMUU) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51015cm) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z12CMRE) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z10CMPDUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH18_6Z18CMRE) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD13-24cm) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD21CMUU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD5cm) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101520) AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,9) pH Monitoring Probe (PH2C10CM) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD10CMUU) Electrolytic Gel for pHmetry and ZpH (ACAL122) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD15CMUU) pH Monitoring Probe (PH2C13CM) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z16CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z16CMRE) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z14CMUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z22CMUU) pH Monitoring Probe (PH2C18CM) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z20CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z10CMPDRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z14CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD11CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (2PH15_6Z15CMRE) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z12CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1324UU) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A51015UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD23cm) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD723UU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z12CMUU) pH Monitoring Probe (PH2C15CM ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z18CMUU) pH Monitoring Probe (PH3C-15-19CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD13cm) pH 7 Buffer Solution ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z20CMUU) pH Monitoring Probe (PH3C-15-20CM) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD21cm) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101520UU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD11cm) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD10cm) AL-4 Catheter pHmetry Esophageal (1CpHAL4AD1,4) pH Monitoring Probe (PH2C12CM) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD20CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z18CMRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD12CMUU) pH Monitoring Probe (PH1CAD) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD51520cm) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD8CMUU) AL-4 Catheter pHmetry Esophageal (1CpHAL4P1,4) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD5CMUU) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD7cm) ZpH Catheter ImpedancepHmetry Esophageal (2PH18_6Z18CMUU) pH Monitoring Probe (PH2C21CM) AL-4 Catheter pHmetry Esophageal - External Reference (1PHAL4ADUU) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD13CMUU) pH Monitoring Probe (PH3C-15-18CM) AL-4 Equipment for Impedance-pHmetry Esophageal (AL-4 pH; AL-4 ZpH) AL-4 Catheter pHmetry Esophageal (4CpHAL4AD101521) pH Monitoring Probe (PH2C8CM) pH Monitoring Probe (PH2C20CM) ZpH Catheter ImpedancepHmetry Esophageal (2PH15_6Z15CMUU) AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-19cm) AL-4 Catheter pHmetry Esophageal (2CpHAL4AD18cm) ZpH Catheter ImpedancepHmetry Esophageal (IG2PH6Z18CMUU) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (1PH6Z7CMPDRE) AL-4 Catheter pHmetry Esophageal - External Reference (2PHAL4AD23CMUU) AL-4 Catheter pHmetry Esophageal - External Reference (4PHAL4A101821UU) pH 1 Buffer Solution AL-4 Catheter pHmetry Esophageal (3CpHAL4AD15-18cm) AL-4 Catheter pHmetry Esophageal - External Reference (3PHAL4AD1518UU) pH Monitoring Probe (PH1C-PED1,4) ZpH Catheter ImpedancepHmetry Esophageal - External Reference (IG2PH6Z18CMRE) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z14CMUU) ZpH Catheter ImpedancepHmetry Esophageal (1PH6Z16CMUU ) BP-1 Urodynamics Infusion Pump - Peristaltic Pump PVC Rectal Balloon Probe (SDBL10PVC42; SDBL12PVC42; SDBL10PVC124; SDBL12PVC124) Silicone Tube for Infusion Mechanisms (DUCTUB001) UROCOMMANDER Equipment with EMG Biofeedback Balloon Probe (SB-BIO) Double Lumen Pig Tail Probe (4.1860B; SDL-PG-6FR; SDL-PG-7FR; SDL-PG-8FR) Connector for Minimally Invasive Male Urodynamics (DUAUMI) Infusion Set for Urodynamics Infusion Pump (EQUIPOBP1) UROCOMMANDER Equipment for Flowmetry UROCOMMANDER Equipment for Urodynamics Urodynamics Catheter Extender (EXTUR10FR120) Rectal Balloon Probe (B08FR-4; B10FR-4; B12FR-4) Double Lumen Probe (DL6FR; DL6FR-2F; DL6FR-30; DL7FR; DLFR8) UROCOMMANDER Equipment for Flowmetry Uroflow UROCOMMANDER Equipment for Biofeedback CFE-P-26C4.3-0.5; CFE-P-26C4.3-0.7; CFE-P-26C4.7-0.5; CFE-P-26C4.7-0.7; CFE-P-28C3.2-0.5; CFE-P-28C3.2-0.7; CFE-P-30C3.2-0.5; CFE-P-30C3.2-0.7; CFE-P-30C4.2-0.5; CFE-P-30C4.2-0.7; CFE-P-30C4.3-0.5; CFE-P-30C4.3-0.7; CFE-P-18C4.3-0.7-20cm; CFE-P-18C4.3-0.7-21cm; CFE-P-18C4.3-0.7-25cm; CFE-P-18C4.3-0.7-30cm; CFE-P-18C4.7-0.5-20cm; CFE-P-18C3.2-0.7-21cm; CFE-P-18C3.2-0.7-25cm; CFE-P-18C3.2-0.7-30cm; CFE-P-18C4.2-0.5-20cm; CFE-P-18C4.2-0.5-21cm; CFA-P-36C-4.7-6cm/RD2 CFA-P-12C-4.7-6cm/RD1; CFA-P-12C-4.7-6cm/SP1; CFA-P-14C-4.7-3cm; CFA-P-14C-4.7-4.5cm; CFA-P-14C-4.7-6cm; CFA-P-20C-4.7-6cm; CFA-P-22C-4.7-3cm; CFA-P-22C-4.7-4.5cm; CFA-P-22C-4.7-6cm; CFA-P-24V4; CFA-P-24V4.7; CFA-P-28C-4.7-6cm; CFA-P-30C-4.7-3cm; CFA-P-30C-4.7-4.5cm; CFA-P-30C-4.7-6cm; CFA-P-32C-4.7-3cm; Anorectal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 Channels (CFA) CFE-P-30C4.7-0.5; CFE-P-30C4.7-0.7; CFE-P-32C3.2-0.5; CFE-P-32C3.2-0.7; CFE-P-32C4.2-0.5; CFE-P-32C4.2-0.7; CFA-P-24C-4.7-3cm; CFA-P-24C-4.7-4.5cm; CFA-P-24C-4.7-6cm; CFA-P-24C-4.7-6cm/RD1; CFA-P-24C-4.7-6cm/RD2; CFE-P-36C3.2-0.7-21cm; CFE-P-36C3.2-0.7-25cm; CFE-P-36C3.2-0.7-30cm; CFE-P-36C4.2-0.5-20cm; CFE-P-36C4.2-0.5-21cm; CFE-P-22C4.2-0.5; CFE-P-22C4.2-0.7; CFE-P-22C4.3-0.5; CFE-P-22C4.3-0.7; CFE-P-22C4.7-0.5; CFE-P-22C4.7-0.7; CFA-P-2C-4.7; CFA-P-2C-4; CFA-P-4C-4.7; CFA-P-4C-4; CFA-P-6C-4.7; CFA-P-6C-4; CFA-P-8C-4.7; CFA-P-8C-4; CFE-P-18C4.7-0.7-25cm; CFE-P-18C4.7-0.7-30cm; CFE-P-20C3.2-0.5; CFE-P-20C3.2-0.7; CFE-P-20C4.2-0.5; CFE-P-20C4.2-0.7; CFE-P-24C3.2-0.5-20cm; CFE-P-24C3.2-0.5-21cm; CFE-P-24C3.2-0.5-25cm; CFE-P-24C3.2-0.5-30cm; CFE-P-24C3.2-0.7-20cm; CFE-P-36C4.7-0.7-25cm; CFE-P-36C4.7-0.7-30cm CFE-P-18C4.2-0.7-30cm; CFE-P-18C4.3-0.5-20cm; CFE-P-18C4.3-0.5-21cm; CFE-P-18C4.3-0.5-25cm; CFE-P-18C4.3-0.5-30cm; CFE-P-12C3.2-0.5; CFE-P-12C3.2-0.7; CFE-P-12C4.2-0.5; CFE-P-12C4.2-0.7; CFE-P-12C4.3-0.5; CFE-P-12C4.3-0.7; CFA-P-10C-4.7; CFA-P-10C-4; CFA-P-12V4.7; CFA-P-12V4; CFA-P-12C-4.7-3cm; CFA-P-12C-4.7-4.5cm; Catheter Washer (LAVCAT-8CMU; LAVCAT-24CMU; LAVCAT-36CMU) CFE-P-14C4.3-0.5; CFE-P-14C4.3-0.7; CFE-P-14C4.7-0.5; CFE-P-14C4.7-0.7; CFE-P-16C3.2-0.5; CFE-P-16C3.2-0.7; CFE-P-24C4.2-0.7-30cm; CFE-P-24C4.3-0.5-20cm; CFE-P-24C4.3-0.5-21cm; CFE-P-24C4.3-0.5-25cm; CFE-P-24C4.3-0.5-30cm; CFE-P-24C3.2-0.7-21cm; CFE-P-24C3.2-0.7-25cm; CFE-P-24C3.2-0.7-30cm; CFE-P-24C4.2-0.5-20cm; CFE-P-24C4.2-0.5-21cm; CFE-P-16C4.2-0.5; CFE-P-16C4.2-0.7; CFE-P-16C4.3-0.5; CFE-P-16C4.3-0.7; CFE-P-16C4.7-0.5; CFE-P-16C4.7-0.7; CFA-P-36V4.7; CFA-P-36C-4.7-3cm; CFA-P-36C-4.7-4.5cm; CFA-P-36C-4.7-6cm; CFA-P-36C-4.7-6cm/RD1; CFE-P-36C4.2-0.7-30cm; CFE-P-36C4.3-0.5-20cm; CFE-P-36C4.3-0.5-21cm; CFE-P-36C4.3-0.5-25cm; CFE-P-36C4.3-0.5-30cm; CFE-P-32C4.3-0.5; CFE-P-32C4.3-0.7; CFE-P-32C4.7-0.5; CFE-P-32C4.7-0.7; CFE-P-34C3.2-0.5; CFE-P-34C3.2-0.7; Esophageal Easy Connect Catheters - 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36 (CFE) CFE-P-2C4.7-0.7; CFE-P-4C3.2-0.5; CFE-P-4C3.2-0.7; CFE-P-4C4.2-0.5; CFE-P-4C4.2-0.7; CFE-P-4C4.3-0.5; CFE-P-4C4.3-0.7; CFE-P-24C4.2-0.5-25cm; CFE-P-24C4.2-0.5-30cm; CFE-P-24C4.2-0.7-20cm; CFE-P-24C4.2-0.7-21cm; CFE-P-24C4.2-0.7-25cm; CFE-P-36C4.2-0.5-25cm; CFE-P-36C4.2-0.5-30cm; CFE-P-36C4.2-0.7-20cm; CFE-P-36C4.2-0.7-21cm; CFE-P-36C4.2-0.7-25cm; CFE-P-2C3.2-0.5; CFE-P-2C3.2-0.7; CFE-P-2C4.2-0.5; CFE-P-2C4.2-0.7; CFE-P-2C4.3-0.5; CFE-P-2C4.3-0.7; CFE-P-2C4.7-0.5; CFE-P-36C4.7-0.5-21cm; CFE-P-36C4.7-0.5-25cm; CFE-P-36C4.7-0.5-30cm; CFE-P-36C4.7-0.7-20cm; CFE-P-36C4.7-0.7-21cm; CFE-P-18C3.2-0.5-20cm; CFE-P-18C3.2-0.5-21cm; CFE-P-18C3.2-0.5-25cm; CFE-P-18C3.2-0.5-30cm; CFE-P-18C3.2-0.7-20cm; CFE-P-12C4.7-0.5; CFE-P-12C4.7-0.7; CFE-P-14C3.2-0.5; CFE-P-14C3.2-0.7; CFE-P-14C4.2-0.5; CFE-P-14C4.2-0.7; CFE-P-10C4.2-0.5; CFE-P-10C4.2-0.7; CFE-P-10C4.3-0.5; CFE-P-10C4.3-0.7; CFE-P-10C4.7-0.5; CFE-P-10C4.7-0.7; CFE-P-28C4.2-0.5; CFE-P-28C4.2-0.7; CFE-P-28C4.3-0.5; CFE-P-28C4.3-0.7; CFE-P-28C4.7-0.5; CFE-P-28C4.7-0.7; CFE-P-4C4.7-0.5; CFE-P-4C4.7-0.7; CFE-P-6C3.2-0.5; CFE-P-6C3.2-0.7; CFE-P-6C4.2-0.5; CFE-P-6C4.2-0.7; CFE-P-6C4.3-0.5; CFE-P-20C4.3-0.5; CFE-P-20C4.3-0.7; CFE-P-20C4.7-0.5; CFE-P-20C4.7-0.7; CFE-P-22C3.2-0.5; CFE-P-22C3.2-0.7; CFA-P-26C-4.7-3cm; CFA-P-26C-4.7-4.5cm; CFA-P-26C-4.7-6cm; CFA-P-28C-4.7-3cm; CFA-P-28C-4.7-4.5cm; CFE-P-36C3.2-0.5-20cm; CFE-P-36C3.2-0.5-21cm; CFE-P-36C3.2-0.5-25cm; CFE-P-36C3.2-0.5-30cm; CFE-P-36C3.2-0.7-20cm; CFA-P-18C-4.7-6cm/RD1; CFA-P-18C-4.7-6cm/RD2; CFA-P-18C-4.7-6cm/SP1; CFA-P-20C-4.7-3cm; CFA-P-20C-4.7-4.5cm; CFE-P-8C4.3-0.5; CFE-P-8C4.3-0.7; CFE-P-8C4.7-0.5; CFE-P-8C4.7-0.7; CFE-P-10C3.2-0.5; CFE-P-10C3.2-0.7; CFE-P-6C4.3-0.7; CFE-P-6C4.7-0.5; CFE-P-6C4.7-0.7; CFE-P-8C3.2-0.5; CFE-P-8C3.2-0.7; CFE-P-8C4.2-0.5; CFE-P-8C4.2-0.7; Single Connector Multiway (CUM8V; CUM12V; CUM24V; CUM36V; TP1; TP2) CFE-P-34C4.2-0.5; CFE-P-34C4.2-0.7; CFE-P-34C4.3-0.5; CFE-P-34C4.3-0.7; CFE-P-34C4.7-0.5; CFE-P-34C4.7-0.7; CFE-P-36C4.3-0.7-20cm; CFE-P-36C4.3-0.7-21cm; CFE-P-36C4.3-0.7-25cm; CFE-P-36C4.3-0.7-30cm; CFE-P-36C4.7-0.5-20cm; CFA-P-32C-4.7-4.5cm; CFA-P-32C-4.7-6cm; CFA-P-34C-4.7-3cm; CFA-P-34C-4.7-4.5cm; CFA-P-34C-4.7-6cm; CFA-P-36V4; CFE-P-24C4.3-0.7-20cm; CFE-P-24C4.3-0.7-21cm; CFE-P-24C4.3-0.7-25cm; CFE-P-24C4.3-0.7-30cm; CFE-P-24C4.7-0.5-20cm; CFA-P-16C-4.7-3cm; CFA-P-16C-4.7-4.5cm; CFA-P-16C-4.7-6cm; CFA-P-18C-4.7-3cm; CFA-P-18C-4.7-4.5cm; CFE-P-18C4.2-0.5-25cm; CFE-P-18C4.2-0.5-30cm; CFE-P-18C4.2-0.7-20cm; CFE-P-18C4.2-0.7-21cm; CFE-P-18C4.2-0.7-25cm; CFE-P-24C4.7-0.5-21cm; CFE-P-24C4.7-0.5-25cm; CFE-P-24C4.7-0.5-30cm; CFE-P-24C4.7-0.7-20cm; CFE-P-24C4.7-0.7-21cm; CFE-P-18C4.7-0.5-21cm; CFE-P-18C4.7-0.5-25cm; CFE-P-18C4.7-0.5-30cm; CFE-P-18C4.7-0.7-20cm; CFE-P-18C4.7-0.7-21cm; CFE-P-24C4.7-0.7-25cm; CFE-P-24C4.7-0.7-30cm; CFE-P-26C3.2-0.5; CFE-P-26C3.2-0.7; CFE-P-26C4.2-0.5; CFE-P-26C4.2-0.7; H2X Hydrogen Breath Analyzer MULTIPLEX 8; MULTIPLEX 12; MULTIPLEX 18; MULTIPLEX 24; MULTIPLEX 36 MULTIPLEX High-Resolution Esophageal/Anorectal Manometry Equipment

Establishment Types

Manufacture Medical Device